BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210383 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08156
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 18, 2013
    Report Date
    May 23, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE ICD IDENTIFIED NO ANOMALIES ON THE DEVICE CASE. AS NOTED CLINICALLY, REVIEW OF DEVICE MEMORY REVEALED TWO SHOCK LEAD SHORTED FAULTS AND TWO CHARGE TIME EXCEEDED FAULTS. FURTHER REVIEW NOTED A LOW IMPEDANCE FAULT DURING THE THIRD EPISODE. THE FIRST TWO EPISODES WERE ABORTED. THE DEVICE BATTERY STATUS MOVED TO ELECTIVE REPLACEMENT INDICATOR (ERI) AND SUBSEQUENTLY END OF LIFE (EOL) DUE TO A CHARGE TIMEOUT. AN X-RAY OF THE DEVICE REVEALED THAT THE INTERNAL HIGH VOLTAGE FUSE WAS DAMAGED (I.E., NO LONGER INTACT). THE DAMAGE TO THE FUSE MOST LIKELY OCCURRED DURING DELIVERY OF THE 31 JOULE SHOCK THAT RESULTED IN THE SHORTED SHOCK LEAD FAULT. THE DAMAGE TO THE HIGH VOLTAGE FUSE PREVENTED ANY SUBSEQUENT CHARGING OF THE HIGH VOLTAGE CAPACITORS AND DELIVERY OF SHOCK THERAPY. AS A RESULT, THE SECOND HIGH VOLTAGE CHARGE ATTEMPT CAUSED THE DEVICE TO DECLARE ERI AND ULTIMATELY EOL BECAUSE IT COULD NOT SUCCESSFULLY COMPLETE CHARGING WITHIN 30 SECONDS, DESPITE THE FACT THAT SIGNIFICANT BATTERY VOLTAGE AND CAPACITY REMAINED. THE REPORTED LEAD SEGMENT WAS NOT RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE REPLACEMENT, A FAULT CODE WARNING WAS INDICATED WHILE PERFORMING THE DEFIBRILLATION THRESHOLD (DFT) TEST WITH THE NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (F051; ICD) AND THE CHRONIC LEAD (0165). THERE WAS NO INDUCTION OF A T-WAVE SHOCK. UPON REINVESTIGATION, A LEAD INSULATION ISSUE ON THE 0165 WAS OBSERVED, AND REPAIRED ONSITE WITH A LEAD REPAIR KIT. THE PATIENT WAS PREPARED FOR A SECOND INDUCTION, AND THIS TIME, THE ICD WAS UNABLE TO SHOCK WITH 31J. THE FAULT CODE WARNING DISPLAYED A SECOND TIME, AND THE PATIENT WAS SUCCESSFULLY EXTERNALLY DEFIBRILLATED. THE PHYSICIAN ELECTED TO REPLACE THE CHRONIC 0165 LEAD WITH A NEW 0185 LEAD. MEASUREMENTS WERE STABLE; HOWEVER, AFTER A BRIEF TIME, A TWITCH WAS NOTICED WITH THE PATIENT, AND THRESHOLD MEASUREMENTS HAD RAISED MORE THAN TWICE THE INITIAL VALUES. THE 0185 LEAD REMAINED IN THE SAME LOCATION AS THE CHRONIC 0165 LEAD PREVIOUSLY. AN ECHOCARDIOGRAM WAS PERFORMED, AND THERE WAS NO INDICATION OF A PERFORATION OR OTHER CONCERN. A CAPACITOR REFORM WAS PERFORMED, AND THE CHARGE TIME WAS 45S. THE ICD REGISTERED ELECTIVE REPLACEMENT INDICATOR (ERI). THIS ATTEMPTED F051 WAS EXPLANTED, AND A SECOND F051 ICD WAS SUCCESSFULLY IMPLANTED WITH THE NEW 0185 LEAD AND DISPLAYED STABLE MEASUREMENTS. NO TWITCHING WAS OBSERVED WITH THE PATIENT AFTER IMPLANT AS PREVIOUSLY NOTED WITH THE ATTEMPTED F051. THE PHYSICIAN ELECTED TO FORGO ANY ADDITIONAL DFT TESTING AS THE PATIENT¿S VITAL PARAMETERS WERE NOT VERY GOOD. THE FIRST ATTEMPTED F051 ICD WILL BE RETURNED WITH A PORTION OF THE 0165 CUT LEAD. THE REMAINDER PORTION OF THE 0165 LEAD WAS SURGICALLY ABANDONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310562 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0165

    Patients

    Seq Age Sex Outcome Treatment
    1 F051| 0185| 0165| 1860